Development and evaluation of a decision-making aid for couples hesitant about transitioning from infertility treatment to advanced assisted reproductive technology: a usability and feasibility study

Objectives The aims of this study were (1) to develop a decision-making aid for couples hesitant about transitioning from infertility treatment to advanced assisted reproductive technology, (2) to examine the adequacy of this aid, and (3) to evaluate its usability. After the first version of the decision-making aid was created, the first version was supervised and finally a prototype of the decision-making aid was completed. We conducted a feasibility study from February to March 2022. We used a quantitative cross-sectional descriptive design involving 22 medical professionals and infertility survivors recruited. Results Twenty-two participants (3 reproductive medical specialists, 11 nurses who specialize in reproductive medicine, and 8 infertility survivors) were included in the final analysis (91.7% valid response rate). Of these participants, 81.8% answered Agree regarding “Easy-to-read degree of charts”, 17 (77.3%) answered It is just the right amount regarding “Appropriateness of information volume”, 81.8% answered Agree regarding “Ease of understanding content”, and 90.9% answered Good regarding “Overall performance”. From the opinions received, we extracted 4 categories: “Useful for decision making,” “Suitable for providing information,” “Useful in clinical practice,” and “Needs improvement.” Certain degrees of surface validity and content validity were confirmed for the trial version of the decision-making aid.


Introduction
The number of women suffering from infertility worldwide is estimated at 40.5-186 million, and this number has continued to grow over the years [1,2].Conversely, the number of newborns conceived using advanced assisted reproductive technology (ART) has also increased year by year [3][4][5].Patients undergoing infertility treatment have physical, psychological, economic, and time burdens [6].In particular, various problems have been experienced by patients undergoing ART, such as increased frequency of multiple pregnancies [7], age-related problems [8], non-insurance coverage of the expensive medical treatment [8], increased depression and anxiety during the ART cycle [9], and psychological distress [9,10].Stress and fear due to ART failure have also been experienced [11].Specifically, the high cost and burden of ART cause stress among care recipients [12], making it difficult for them to transition from infertility treatment to ART.
During infertility treatment, women experience great conflict in determining the optimal stages of treatment, including the correct timing and methods such as artificial insemination [13].Acceptance of ART is influenced by a couple's attitude, family's mindset, and their perceptions [14].Addressing decision-making conflicts in couples undergoing fertility treatment is an important undertaking of healthcare providers [15].In Japan where there is no age limit for fertility treatment, there are still no standards for terminating such treatment.This results in a conflict between continuing and terminating fertility treatment [16].Therefore, there is a need for a decisionmaking support for resolving decision-making conflicts in transitioning from fertility treatment, including information about treatment termination.A decision-making aid serves as a supplementary tool when presented with two or more options.A systematic review [17] that looked into the effects of a decision-making aid showed increased knowledge, less conflict, and greater satisfaction with the couple's individual decisions.Decisionmaking aids, such as those from the Ottawa Hospital Research Institute [18], usually consist of a collection of aids for various themes.However, to our knowledge, there is still no decision-making aid for transitioning from infertility treatment to ART.The aims of this study were (1) to develop a decision-making aid for couples hesitant about transitioning from infertility treatment to ART, (2) to examine the adequacy of this decision-making aid, and (3) to evaluate its usability.

Participants and procedures
Cooperation for research participation was obtained from the directors of two infertility treatment facilities.The inclusion criteria were as follows: (1) doctors specializing in reproductive medicine who are involved in fertility treatment, (2) nurses/midwives qualified as reproductive consultants or certified nurses involved in fertility nursing, and (3) ART-experienced patients.This distribution made it possible to obtain representative opinions based on treatment experience.The exclusion criterion was those in whom written consent was not obtained.The sample size was estimated as 22 participants following the calculation procedure of Nielsen & Landauer [19].Assuming a sample size of λ = 0.20 needed to detect 85% of problems regarding usability of treatment, and an expected dropout rate of 10%, we calculated that 22 people would be needed for the study.In this regard, we planned to recruit 6 to 7 each of medical doctors, nurses/midwives, and previous patients.
The survey period was from February 2023 to April 2023.The participants were introduced by the director of the research cooperating facility.The researchers explained the aims of the study to the participants verbally and in writing.After giving consenting, the participants were given a booklet on "Decision-Making Aids" and a questionnaire.After thoroughly viewing the decision-making aid prototype, the participants completed an anonymous questionnaire and mailed it individually.

1) Preparation of the first version of the decision-making aid
We conducted a literature survey on the contents and methods of support for making decisions in patients undergoing fertility treatment.Then, we selected the contents to be included in the decision-making aid.All contents from published papers included in the decisionmaking aid were approved by Japanese academic societies and authors [20][21][22][23][24][25].The decision-making aid was developed to help patients undergoing infertility treatment be able to make decisions when they are hesitant about "transitioning from general infertility treatment to ART" and "ending treatment".The original decision-making aid was created based on the decision aids from Ottawa Hospital Research Institute [18].The decision-making aid was specifically developed following the decision-making guide of the International Patient Decision Aid Standards instrument (IPDASi) [26] to meet all the qualification, accreditation, and quality standards.

2) Supervision of the first edition of decision-making aid
The development of the first edition of the decisionmaking aid was extensively supervised by several reproductive medicine specialists and clinical geneticists.The contents were revised each time.

3) Completion of decision-making aid prototype
The applicability of the decision-making aid in clinical prac-tice was supervised by reproductive medicine specialists and reproductive counsellors at infertility centers.
Content corrections were made based on the comments received, and a temporary version of the decision-making aid was completed in a booklet format.The decisionmaking aid consisted of No. 1 to No. 4 items.No. 1 was about "What is the method for making a decision?",and included various aspects such as "confirmation of who can use it", "how to select fertility treatment", and "how to use the decision-making aid".No. 2 consisted of "What are your options?", and included various aspects such as "considering infertility treatment methods", "comparison of options (general infertility treatment or ART)", and "suspension/interruption of treatment".No. 3 focused on "Think about your option", to consider how important the contents are such as "receiving infertility treatment", "having a child", and "relationship with a partner".No. 4 described the "Decide", such as "confirm your feelings" and "respond if you cannot decide".To confirm the participants' feelings, we used the SURE test [27][28][29][30].

Assessment instruments
1. Demographics We asked the participants about their gender, occupation, years of work experience, years of treatment experience (previous patients only), and preferred selection method.

Evaluation of the face validity of the trial version of the decision-making aid
We asked for a single response by setting options for viewing time, degree of browsing, appropriateness of size, appropriateness of information volume, easy-to-read degree of charts, appropriateness of number of pages, and types of media that are easy to use.

Assessing the surface validity of the trial version of the decision-making aid
We set options for ease of understanding, usability, degree of recommendation to patients, balance of content, and overall impression, and asked for a single response.

Data analysis
Basic statistics for each variable were calculated, and the face validity and content validity of the decision-making aid were obtained from the frequency distribution tables.After summarizing the free-text data, we divided the data into labels and extracted categories for each similar content.The open-ended remarks were analyzed using constant comparative analysis.
The average viewing time was 22.8 min, and 77.3% of the participants answered It is just the right amount regarding Appropriateness of information volume (Table 1).Appropriateness of the surface was rated on a scale of 5, with 81.8% evaluating the charts as easy to read.Regarding the Appropriateness of number of pages, 45.5% of the participants answered just the right amount, and 54.5% answered slightly more.Regarding Ease of understanding content, 81.8% of the participants answered Agree.Regarding Usefulness when selecting ART, 90.9% answered Agree.Regarding Availability at the end of treatment, 90.9% answered Agree.Regarding Degree of recommendation to patients, 81.8% answered Agree.As regards Overall performance, 81.8% of the participants responded that the overall performance was Very good, 81.8% as Good, and 9.1% as Normal.
The content analysis of the open-ended responses revealed 4 categories: (1) Useful for decision making, (2) Suitable for information provision, (3) Useful in clinical practice, and (4) Needs improvement (Table 2).

Discussion
In this study, we developed a decision-making aid for couples hesitant about transitioning from infertility treatment to ART, examined the adequacy of the decisionmaking aid, and evaluated its usability.The face validity and content validity of the decision-making aid showed high practical usefulness and high comprehensibility.From the overall results, the decision-making aid was assessed to be useful and applicable to patients undergoing infertility treatment.
Notably, there were also some contents that were not very helpful, and the participants did not completely agree with these contents.In the Ease of understanding content, 18.2% of the participants Neither agreed nor disagreed with the understandability of the content, and 9.1% of the participants did not find the decision-making aid useful when selecting ART or ending treatment.
Thus, there is a need to scrutinize more thoroughly such information on the decision-making aid.Additionally, some of the quotes were outdated and needed  updating.As fertility treatment is constantly evolving, treatment-related content must be revised with the utmost care.Putting things into perspective, the decision-making aid was originally made not only to provide information, but also to help those undergoing infertility treatment to make decisions on their own with conviction.In the evaluation of the usefulness of each content of the decision-making aid (Fig. 1), particularly the third category "Think about your options", the patients can think about how important it is to "get fertility treatment", "get ART", and "have a child".A decision-making aid is used for complex health decisions [31].Such aid has one or more rational options, each with its own strengths and weaknesses, and it is up to the values of an individual to determine which option is best [26].A decision-making aid is intended to inform patients of their options, clarify their personal values, and facilitate discussions with their healthcare providers [26].Such aid improves knowledge, the accuracy of risk perception, alignment with personal values, and conflict [17].This facilitates decision-making, coupled with greater satisfaction and less decision regret [32].A decision-making aid is suggested to reduce treatment conflict and enables more informed decision-making in patients undergoing infertility treatment.In the future, it is necessary to use a decision-making aid in actual patients to evaluate its usefulness.

Conclusions
We developed a decision-making aid for couples hesitant about transitioning from infertility treatment to ART.We also examined its adequacy evaluated its usability.More than 81.8% of reproductive physicians, reproductive nurses, and those who have experienced infertility treatment rated the content validity of the decision-making aid highly.The participants opined that the decisionmaking aid was "Useful for decision making, " "Ideal for providing information, " and "Useful in clinical practice, " but it also "Needs improvement".Couples hesitant about transitioning from infertility treatment to ART or ending infertility treatment can obtain correct evidencebased information, which is anticipated to be helpful for self-decision.Midwives and nurses can also use the decision-making aid to provide evidence-based information when supporting the decision-making of couples who have doubts on using ART or ending their infertility treatment.

Limitations
The decision-making aid described herein is in the postdevelopment stage and is being evaluated by healthcare professionals and previous fertility patients.Patients undergoing infertility treatment have not yet been evaluated.The corrections pointed out by such patients have not yet been incorporated in the decision-making aid.
The participants were asked to freely describe their opinions on what they liked about the trial version of the decision-making aid, what they did not like, what other contents were necessary, and what they needed to improve the decision-making aid.

Fig. 1
Fig. 1 Evaluation of the usefulness of each content of the decision-making aid (N = 22)

Table 1
Face validity content validity evaluation of decisionmaking aid trial version (N = 22)

Table 2
22)nions regarding the trial version of the decisionmaking aid from the participants (N =22)